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Sochi

FDA UDI

Class II (US FDA UDI)

by Altus Spine

Identity

Trade Name
Sochi FDA UDI
Generic Name
Bone tap, reprocessed FDA UDI
Device Name
Tap, Round Tip, 3.5mm FDA UDI
Model / Reference
A16-40-0535 FDA UDI
Description
Tap, Round Tip, 3.5mm FDA UDI

Identifiers

Primary DI / UDI-DI
00843210173191 FDA UDI
510(k) Number
K210887 FDA UDI
FDA Product Code
KWP FDA UDI
NKG FDA UDI
GMDN Term
Bone tap, reprocessed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3075 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone tap, reprocessed

Sochi by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone tap, reprocessed.

Cleared under the same submission

K210887 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Altus Spine

Sources (1)

  • FDA UDI cf1ce15b-f451-4b32-a9b8-8c17aa32c438 35 fields · synced May 30, 2026